Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Job Title: Lead Document Control Administrator
2nd shift position. 2pm-1030 pm M-F with training on 1st shift.
Requisition ID:
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
St. Louis, MO
How will you make an impact?
Supports St. Louis site with tasks like issuing batch records and related documents for biologics manufacturing.
What you will do:
Coordinate shift exchanges, meetings, and attend important meetings to address area needs and changes. Also, participate in lean activities, cross-functional activities, and shift huddles.
Provides coverage in supervisor absences and delegate duties efficiently to support production demands.
Schedule daily/weekly department assignments.
Function as liaison with other groups within the organization and serve as a qualified trainer for department processes, procedures, audits, and inspections.
Assist in the creation, implementation, and maintenance of department training curriculum, and train new/current colleagues.
Maintain up-to-date training records and qualified trainer certification.
Initiate and approve deviations, complete CAPA requirements, perform SOP revisions, and implement new processes within the department.
Support audits (internal/external), inspections, and applicable preparation & closure activities.
Document all activities to meet cGMP requirements and maintain cGMP compliance in assigned work while following all safety procedures.
Perform all document-related tasks such as making documents effective, printing, periodic review, withdrawal, reconciliation, issuance, archiving, scanning, record retention, document release, and accountability.
Generate applicable reports and data to support departmental metrics and job functions.
Align with all job-related safety and other training requirements.
Support 24/7 coverage as needed, including evenings, weekends, and holidays.
Complete other assigned tasks.
How will you get here?
Education
Bachelor's degree preferred
Experience
1+ years experience in documentation or experience in a cGMP or pharmaceuticals.
1+ years leadership experience preferred
Knowledge, Skills, and Abilities
Digital literacy, including experience in using Smartsheet, SAP, Trackwise, and MS Office applications like Word and Excel. Proficient in computer systems associated with quality assurance functions, such as document searches, review and approval, sample labels (LIMS), batch record release, and document issuance. Strong communication skills to establish and maintain positive relationships with employees and the public, demonstrating tact in handling sensitive matters. Excellent attention to detail and interpersonal skills. Self-motivated, mature, independent, and detailed. Capable of growing in a fast-paced environment, prioritizing multiple tasks simultaneously.
Physical Requirements:
The position requires basic physical skills like walking, standing, and bending, as well as the ability to lift and carry light to medium weights. It also requires good hand and finger dexterity for typing, and clear vision for using a computer and reading.
At Thermo Fisher Scientific, each one of our 65,000 outstanding minds has a unique story to tell. Join us and chip in to our mission-enabling our customers to make the world healthier, cleaner, and safer.
